NCT02792166

Brief Summary

The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades. Surgery remains the cornerstone of treatment of obesity and related comorbidities such as type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a) those that cause restriction, and b) those that add a malabsorptive component to restriction. Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most frequently performed procedure in North America. Interestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS procedure has been shown to be significantly more effective than RYGB in achieving durable weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes, the performance of BPD-DS is highly institution dependant and comprises less than 5% of the annual bariatric procedures performed worldwide. Common reservations against BPD-DS are related to the side effects of the procedure, and include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition. Furthermore, longer operative times and surgical technical challenges are also reasons for lower prevalence of the BPD-DS procedure. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is a suitable second-stage or salvage procedure for severely obese patients with inadequate weight loss or resolution of obesity-related comorbidities after SG. Despite showing excellent results of up to 5 years with acceptable postoperative morbidity, all the literature on SADI-S originates from a single center and has not been compared directly with BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients. This project has three specific aims:

  1. 1.To evaluate feasibility and short-term safety of SADI-S.
  2. 2.To evaluate short and long-term beneficial outcomes.
  3. 3.To evaluate and compare long-term morbidity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

3.6 years

First QC Date

June 2, 2016

Last Update Submit

September 29, 2025

Conditions

ObesityMorbid Obesity

Keywords

Morbid obesityMetabolic syndromeMetabolic surgeryBariatric surgerySADIBPD-DS

Outcome Measures

Primary Outcomes (2)

  • Short-term Safety Assessment

    To evaluate feasibility and short-term safety of SADI-S, we will assess operative parameters (procedure time, inadvertent injuries, need for conversion to laparotomy, and transfusion of blood products) and 30-day postoperative adverse events (length of stay, superficial/deep surgical site infection, leak, venous thromboembolism (VTE), need for reintervention and readmission).

    30 days

  • Weight loss

    %EWL and change in BMI as compared to preoperative reference values

    5 years

Secondary Outcomes (4)

  • Long-term Morbidity Assessment

    5 years

  • Remission of T2DM

    5 years

  • Resolution/Improvement in other obesity related comorbidities

    5 years

  • Quality of Life Assessment

    5 years

Study Arms (2)

BPD-DS

ACTIVE COMPARATOR

BPD-DS involves creating a sleeve gastrectomy and creation of a Roux-en-Y bypass involving a Roux limb (150cm) which is anastomosed to the transected first-stage of the duodenum and a short common channel (100cm).

Procedure: BPD-DS

SADI-S

EXPERIMENTAL

SADI-S involves creating a sleeve gastrectomy but simplifies the bypass part of the BPD-DS by a single anastomosis of a loop of jejunum at 250cm from the ileocecal valve (longer common channel) to the transected first-stage of the duodenum instead of the Roux-en-Y construct.

Procedure: SADI-S

Interventions

BPD-DSPROCEDURE

Biliopancreatic Diversion with Duodenal Switch

Also known as: Bariatric/metabolic surgery
BPD-DS
SADI-SPROCEDURE

Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy

Also known as: Bariatric/metabolic surgery
SADI-S

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥18 years and ≤60 years
  • Fulfill criteria for bariatric surgery as coined by National Institutes of Health
  • Give written informed consent

You may not qualify if:

  • Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:
  • Presence of the following baseline comorbidities:
  • Congestive heart failure (CHF),
  • Chronic kidney disease (CKD) stage 3-5 (or GFR \<60 ml/min per 1.73 m2),
  • Inflammatory bowel disease (IBD),
  • Pulmonary hypertension (PHTN),
  • Cirrhosis.
  • Severe gastroesophageal reflux disorder (GERD) +/- presence of any Barrett's disease
  • Individuals who were found by any member of the multidisciplinary team (nutritionist, nurse, psychologist, and surgeon) to be at risk for lack of support and poor compliance (e.g. ≥2 missed appointments without a valid justification)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (7)

  • Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.

    PMID: 20798995RESULT

  • Sanchez-Pernaute A, Rubio MA, Cabrerizo L, Ramos-Levi A, Perez-Aguirre E, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) for obese diabetic patients. Surg Obes Relat Dis. 2015 Sep-Oct;11(5):1092-8. doi: 10.1016/j.soard.2015.01.024. Epub 2015 Feb 7.

    PMID: 26048517RESULT

  • Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.

    PMID: 22963820RESULT

  • Sanchez-Pernaute A, Rubio MA, Conde M, Arrue E, Perez-Aguirre E, Torres A. Single-anastomosis duodenoileal bypass as a second step after sleeve gastrectomy. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):351-5. doi: 10.1016/j.soard.2014.06.016. Epub 2014 Jul 10.

    PMID: 25543309RESULT

  • Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.

    PMID: 18040751RESULT

  • Andalib A, Safar A, Bouchard P, Demyttenaere S, Court O. Single Anastomosis Duodenal Switch versus Classic Duodenal Switch: Long-term Outcomes from a Prospective Comparative Cohort Study. Obes Surg. 2023 Dec;33(12):3951-3961. doi: 10.1007/s11695-023-06900-z. Epub 2023 Oct 21.

    PMID: 37864735DERIVED

  • Andalib A, Bouchard P, Alamri H, Bougie A, Demyttenaere S, Court O. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S): short-term outcomes from a prospective cohort study. Surg Obes Relat Dis. 2021 Feb;17(2):414-424. doi: 10.1016/j.soard.2020.09.015. Epub 2020 Sep 14.

    PMID: 33158766DERIVED

MeSH Terms

Conditions

ObesityObesity, MorbidMetabolic Syndrome

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Amin Andalib, MD MSc FRCSC

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MSc FRCSC

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 7, 2016

Study Start

June 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2024

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)